Impact of Reducing Antihypertensive Treatment on Mortality in Frail Subjects With Low Systolic Blood Pressure (SBP).
RETREAT-FRAIL
2 other identifiers
interventional
1,048
1 country
124
Brief Summary
The investigators hypothesize that a gradual reduction in antihypertensive treatment in medical-social institutions patients with low systolic blood pressure (SBP) can improve survival through a controlled increase in SBP and a decrease in secondary morbidity due to 'overmedication'. Accordingly, the investigators propose a randomized, case/control trial in NH patients ≥ 80 years with a SBP\<130 mmHg with \>1 anti-Htn drugs. This trial will consist of two parallel arms: the intervention arm will entail antihypertensive drug step-down, while the control arm will comprise the standard anti-hypertensive treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable hypertension
Started Oct 2018
Longer than P75 for not_applicable hypertension
124 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 31, 2018
CompletedFirst Posted
Study publicly available on registry
March 5, 2018
CompletedStudy Start
First participant enrolled
October 2, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 15, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 15, 2024
CompletedJuly 20, 2025
July 1, 2025
5.9 years
January 31, 2018
July 16, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
All-cause mortality
All-cause mortality in each of the two groups during follow-up (maximum 48 months depending on when the patient was included).
up to 48 months
Secondary Outcomes (9)
Cause of death
up to 48 months
Blood pressure analysis
up to 48 months
Evaluation of frailty
up to 48 months
Evaluation of cognitive function
up to 48 months
Assesment of fall and fractures
up to 48 months
- +4 more secondary outcomes
Study Arms (2)
1: Interventional (drug reduction)
OTHERSTEP DOWN strategy. Proposition of reduction of the number of antihypertensive medication according to: * the systolic blood pressure levels, * co-morbidities
2: Control
OTHERUsual treatment
Interventions
reduction of the number of antihypertensive medication according to: * the systolic blood pressure levels, * co-morbidities
Eligibility Criteria
You may qualify if:
- Male and female patients aged 80 and over
- Patients living in nursing homes
- Patients with a SBP \< 130 mmHg measured in Medical-Social Institutions using the connected blood pressure monitor supplied for the study (average of the last 2 out of 3 measurements after 10 min rest)
- Hypertensive patients whose treatment contains at least 2 antihypertensive molecules and whose treatment has been stabilised for at least :
- weeks in the case of the introduction or discontinuation of an anti-HBP drug
- weeks in the case of a change in the dosage of one of the anti-HBP drugs.
- Patients affiliated to a social security scheme
- Patients who have signed the informed consent form (failing which, the legal representative)
- Patients with dementia or with a severe reduction in physical function (impaired vision, asthenia, advanced osteoarthritis, severe tremors, etc.) and/or cognitive function may be included in this study with the agreement of their carers or family/relatives.
You may not qualify if:
- Patients in whom no antihypertensive molecule can be reduced for specific reasons (heart failure with ejection fraction \<40%, fluid retention due to heart failure, coronary artery disease and diabetic nephropathy).
- Patients with an estimated life expectancy of \<3 months
- Patients who have already been included in this study or in another study at the same time
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (124)
CHU Angoulême (Expert center)
Angoulême, 16000, France
Font Douce (Nursing Home)
Angoulême, 16000, France
Keriolet (Nursing Home)
Auray, 56400, France
Kerleano (Nursing Home)
Auray, 56400, France
Le Parc de la Plesse (Nursing Home)
Avrillé, 49240, France
Sentiers d'Automne (Nursing Home)
Bains-les-Bains, 88240, France
Parisot (Nursing Home)
Bainville-sur-Madon, 54550, France
EHPAD du CH (Nursing Home)
Bar-sur-Seine, 10110, France
EHPAD Fontarce (Nursing Home)
Bar-sur-Seine, 10110, France
USLD du CH (Nursing Home)
Bar-sur-Seine, 10110, France
Saint Charles (Nursing Home)
Bayon, 54290, France
Argia (Nursing Home)
Bayonne, 64100, France
EHPAD du Prisse (Nursing home)
Bayonne, 64100, France
Goxoki (Nursing Home)
Bayonne, 64100, France
EHPAD CH de Valence (Nursing home)
Beauvallon, 26800, France
EHPAD Simone de Beauvoir (Nursing Home)
Béziers, 34500, France
Espace Perréal (Nursing Home)
Béziers, 34500, France
USLD Espace Perréal (Nursing Home)
Béziers, 34500, France
CHU Bordeaux (Expert center)
Bordeaux, 33000, France
La Croix Du Gue (Nursing Home)
Bouguenais, 44340, France
Poincaré (Nursing Home)
Bouxières-aux-Dames, 54136, France
Les Rives d'Ode (Nursing Home)
Carcassonne, 11000, France
Les jardin de Sophia (Nursing Home)
Castelnau-le-Lez, 34057, France
EHPAD de Monges (Nursing Home)
Castres, 81090, France
La Villégiale Saint Jacques (Nursing Home)
Castres, 81090, France
Saint Martin (Nursing Home)
Charmes, 88130, France
Saint Jean (Nursing Home)
Charmois-l'Orgueilleux, 88270, France
EHPAD CH Cotentin Pasteur (Nursing Home)
Cherbourg, 50100, France
Centre pour Personnes Agées (Nursing Home)
Colmar, 68000, France
Diaconnat (Nursing home)
Colmar, 68000, France
Chantereine-Orpea (Nursing Home)
Coubron, 93470, France
Le Hameau de Saubagnacq (Nursing Home)
Dax, 40088, France
CHU Dijon (Expert center)
Dijon, 21000, France
EHPAD CHU Dijon Bourgogne (Nursing Home)
Dijon, 21000, France
Les Bégonias (Nursing Home)
Dijon, 21000, France
Les marguerites (Nursing Home)
Dijon, 21000, France
Port du Canal (Nursing Home)
Dijon, 21000, France
EHPAD Simone Veil (Nursing Home)
Eaubonne, 95600, France
Bas-Château (Nursing Home)
Essey-lès-Nancy, 54270, France
Belfontaine (Nursing Home)
Fontaine-lès-Dijon, 21121, France
Accueil Vologne (Nursing Home)
Granges-sur-Vologne, 88640, France
Vallée Don (Nursing Home)
Guémené-Penfao, 44290, France
EHPAD Orpéa (Nursing home)
La Talaudière, 42350, France
Baudinet De Courcelles (Nursing home)
Lay-Saint-Christophe, 54690, France
CHU Lille (Expert center)
Lille, 59000, France
Les Bateliers (Nursing Home)
Lille, 59000, France
Saint Antoine de Padoue (Nursing Home)
Lille, 59000, France
EHPAD de Lormont (Nursing Home)
Lormont, 33310, France
Sainte Thérèse (Nursing Home)
Ludres, 54710, France
Saint Charles (Nursing Home)
Lunéville, 54300, France
CHU Lyon (Expert center)
Lyon, 69000, France
EHPAD Constant (Nursing Home)
Lyon, 69000, France
La Renaissance-Orpea (Nursing Home)
Marseille, 13000, France
Bon repos (Nursing Home)
Maxéville, 54320, France
Saint Sauveur (Nursing Home)
Maxéville, 54320, France
Félix Marechal (Nursing Home)
Metz, 57000, France
USLD Nouvielle (Nursing Home)
Mont-de-Marsan, 40192, France
Coteaux de Montmorency (Nursing Home)
Montmorency, 78428, France
Jeanne Callarec (Nursing Home)
Montmorency, 78428, France
Antonin Balmès (Nursing Home)
Montpellier, 34000, France
CHU Montpellier (Expert center)
Montpellier, 34000, France
CSPA Bellevue (Nursing Home)
Montpellier, 34000, France
EHPAD du CH (Nursing Home)
Muret, 31600, France
Les Cygnes (Nursing Home)
Nancy, 54000, France
Notre Maison (Nursing home)
Nancy, 54000, France
Saint Charles EHPAD (Nursing Home)
Nancy, 54000, France
Saint Charles USLD (Nursing Home)
Nancy, 54000, France
Saint Joseph (Nursing Home)
Nancy, 54000, France
Saint Stanislas (Nursing Home)
Nancy, 54000, France
Gériatrie - CHRU de Nancy (Expert center)
Nancy, 54500, France
Beauséjour (Nursing Home)
Nantes, 44000, France
CHU Nantes (Expert center)
Nantes, 44000, France
La Chézalière LNA Santé (Nursing Home)
Nantes, 44000, France
CHU Nice (Expert center)
Nice, 06000, France
EHPAD Cimiez du CHU (Nursing Home)
Nice, 06000, France
EHPAD GHAM (Nursing Home)
Nogent-sur-Seine, 10400, France
Bethel (Nursing Home)
Oberhausbergen, 67205, France
Les Jardins d'Olonne (Nursing Home)
Olonne-sur-Mer, 85340, France
Résidence Mer et Estuaire (Nursing Home)
Paimboeuf, 44560, France
APHP (Expert center)
Paris, 75000, France
EHPAD Broca (Nursing Home)
Paris, 75013, France
La Collégiale (Nursing Home)
Paris, 75013, France
Saint Jacques Orpea (Nursing Home)
Paris, 75013, France
Trocadéro-Orpéa (Nursing Home)
Paris, 75016, France
USLD Pessac (Nursing Home)
Pessac, 33318, France
CHU Périgueux (Expert center)
Périgueux, 24000, France
EHPAD Parrot (Nursing Home)
Périgueux, 24000, France
Avant-Garde (Nursing Home)
Pompey, 54340, France
La Salle (Nursing Home)
Pompey, 54340, France
Nazareth (Nursing Home)
Pont-Sainte-Marie, 10150, France
Saint Jean (Nursing Home)
Portieux, 88330, France
Jacques Mellez (Nursing Home)
Raon-l'Étape, 88110, France
CHU Reims (Expert center)
Reims, 51100, France
AHPAD AB2 Wilson (Nursing Home)
Reims, 51454, France
Résidence Roux CHU Reims (Nursing Home)
Reims, 51454, France
Julien Monnard (Nursing Home)
Romilly-sur-Seine, 10100, France
Le Clos des platanes (Nursing Home)
Romilly-sur-Seine, 10100, France
EHPAD Mer Et Pins (Nursing Home)
Saint-Brevin-les-Pins, 44250, France
Mer et Pins Fleur d'Ajonc (Nursing Home)
Saint-Brevin-les-Pins, 44250, France
Mer et Pins les Sylphes (Nursing Home)
Saint-Brevin-les-Pins, 44250, France
Saint Deodat (Nursing Home)
Saint-Dié, 88100, France
Fauriel (Nursing Home)
Saint-Etienne, 42000, France
EHPAD de Saint Genest (Nursing Home)
Saint-Genest, 88700, France
Udazkena (Nursing Home)
Saint-Jean-de-Luz, 64500, France
Hotel Club (Nursing Home)
Saint-Max, 54130, France
EHPAD De Senones (Nursing Home)
Senones, 88210, France
EHPAD Sézanne (Nursing Home)
Sézanne, 51120, France
CHU Strasbourg (Expert center)
Strasbourg, 67000, France
EHPAD Bois Fleuri (Nursing Home)
Strasbourg, 67000, France
EHPAD CHRU Robertsau (Nursing Home)
Strasbourg, 67000, France
La Christinière ACPPA (Nursing Home)
Taluyers, 69440, France
Sainte Sophie (Nursing Home)
Thiaucourt-Regniéville, 54470, France
CHU Toulouse (Expert center)
Toulouse, 31000, France
Jolimont Marengo Orpea (Nursing Home)
Toulouse, 31000, France
Clinique les Minimes (Nursing Home)
Toulouse, 31200, France
Klarene-Orpea (Nursing Home)
Tournan-en-Brie, 77220, France
CHP Cotentin Simone Veil (Nursing Home)
Valognes, 50700, France
EHPAD Maison du Lac (Nursing Home)
Vannes, 56000, France
USLD Maison du Lac (Nursing Home)
Vannes, 56000, France
Sainte Catherine (Nursing Home)
Verdun, 55100, France
Saint Joseph (Nursing Home)
Ville-sur-Illon, 88270, France
Montagne de Reims (Nursing home)
Villers-Allerand, 51500, France
Villa Saint-Pierre (Nursing Home)
Villers-lès-Nancy, 54600, France
Les Buissons (Nursing Home)
Xertigny, 88220, France
Related Publications (1)
Benetos A, Gautier S, Freminet A, Metz A, Labat C, Georgiopoulos I, Bertin-Hugault F, Beuscart JB, Hanon O, Karcher P, Manckoundia P, Novella JL, Diallo A, Vicaut E, Rossignol P; RETREAT-FRAIL Study Group. Reduction of Antihypertensive Treatment in Nursing Home Residents. N Engl J Med. 2025 Nov 20;393(20):1990-2000. doi: 10.1056/NEJMoa2508157. Epub 2025 Aug 29.
PMID: 40879421DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Athanase BENETOS, MD, PhD
CHRU NANCY - Pôle Gérontologie
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 31, 2018
First Posted
March 5, 2018
Study Start
October 2, 2018
Primary Completion
August 15, 2024
Study Completion
August 15, 2024
Last Updated
July 20, 2025
Record last verified: 2025-07