Antihypertensive Effect of Rostafuroxin Compared With Losartan in Hypertensive Patients Bearing Specified Gene Mutations
Antihypertensive Effect of Different Doses of Rostafuroxin in Comparison With Losartan, Assessed by Office and Ambulatory Blood Pressure Monitoring in a Hypertensive Population Selected According to a Specific Genetic Profile
2 other identifiers
interventional
240
3 countries
26
Brief Summary
The principal aim of the study is to demonstrate that Rostafuroxin is able to induce a more pronounced reduction of arterial blood pressure respect to Losartan, in hypertensive patients carrying at least one of the pre-specified gene mutations. In previous studies has been demonstrated that these mutations are able to induce specific alterations inducing an increase of sodium (Na) reabsorption at renal tubular level and an increase of arterial blood pressure. Pilot studies have demonstrated that Rostafuroxin is able to reduce the impact of these alterations, and so directly reverse the increase in blood pressure.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2011
26 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
March 16, 2011
CompletedFirst Posted
Study publicly available on registry
March 22, 2011
CompletedStudy Start
First participant enrolled
May 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedMarch 23, 2011
March 1, 2011
1.2 years
March 16, 2011
March 22, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Systolic Blood Pressure
Automated sitting and standing SBP and DBP will be recorded by physician at baseline (two visits) and at week 2, 5 and 9 of treatement. sitting: after the patient has rested for at least 10 minutes in a quiet room. There are five consecutive sitting BP readings with a 30 to 60 seconds interval between the readings; the mean of the last three sitting BP will be used. The standing BP is measured twice immediately after the patient assumed the standing position.
Week 9 of treatment versus baseline
Secondary Outcomes (3)
Diastolic blood pressure
Baseline (two visits) and then at week 2, 5 and 9 of treatment
Trough-to-peak ratio on Systolic Blood Pressure
Throughout 24 hours ABPM
Number of participants with adverse events
throughout all the study period and follow-up (30 days)
Study Arms (4)
Rostafuroxin 6 micrograms capsules
EXPERIMENTAL1 capsule of ROSTAFUROXIN (6 micrograms) once a day before breakfast.
Rostafuroxin 50 micrograms capsules
EXPERIMENTAL1 capsule of ROSTAFUROXIN (50 micrograms) once a day before breakfast.
Rostafuroxin 500 micrograms
EXPERIMENTAL1 capsule of ROSTAFUROXIN (500 micrograms) once a day before breakfast.
Losartan 50 mg encapsulated
EXPERIMENTAL1 capsule containing one cpr of Losartan 50 mg once a day before breakfast.
Interventions
Eligibility Criteria
You may qualify if:
- Signature of a written informed consent, included informed consent on genotype analysis.
- Naive hypertensive patient (new diagnosed patient, never treated before).
- Documented mild to moderate arterial hypertension: SBP comprised between 140 and 169 mmHg and DBP between 85 and 100 mmHg;
- Presence of at least one mutated genotype or combination of genotypes corresponding to the list provided in the protocol.
You may not qualify if:
- Known causes of secondary or severe or malignant hypertension;
- Significant renal or hepatic disease;
- Cardiac disease requiring prohibited pharmacological treatment or history of myocardial infarction within the last 6 months;
- Atrial Fibrillation or Complete Ventricle Bundle Branch Block;
- First degree AV-block exceeding 240 msec;
- Electrocardiographic evidence of left ventricular hypertrophy;
- Pregnant or nursing women or women of childbearing potential not taking anti-contraceptive medication or not utilizing a double contraceptive method;
- Concomitant therapy with medications that may affect blood pressure;
- Diabetes mellitus (fasting plasma glucose \> 125 mg/dl);
- Statins treatment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- RostaQuo S.p.A.lead
Study Sites (26)
Portiuncula Hospital
Ballinasloe, Galway, Ireland
James Connolly memorial Hospital
Dublin, 15, Ireland
Clinical research centre, Beaumont Hospital
Dublin, 9, Ireland
Unità Operativa di Nefrologia e Dialisi, Ospedale "S. Maria della Scaletta"
Imola, Bologna, 40026, Italy
Ospedale "Santa Maria"
Borgo Val di Taro, Parma, 43023, Italy
Divisione di Cardiologia e UTIC Ospedale "Marianna Giannuzzi"
Manduria, Taranto, 74024, Italy
Reparto di Emodialisi, Ospedale dell'Angelo
Mestre, Venezia, 30174, Italy
U.O. di Nefrologia e Dialisi, Ospedale San Donato
Arezzo, 52100, Italy
U.O Nefrologia, Dialisi e Ipertensione, Policlinico S. Orsola-Malpighi
Bologna, 40138, Italy
Cattedra di Medicina Interna, U.O. Malattie Cardiovascolari, Policlinico Universitario Campus Germaneto
Catanzaro, 88100, Italy
Centro per l'Ipertensione, Ospedale F. Veneziale
Isernia, 86170, Italy
U.O. Nefrologia e Dialisi, Spedali Riuniti
Livorno, 57100, Italy
U.O.C. di Medicina Interna Universitaria 1, Ospedale San Salvatore
L’Aquila, 67100, Italy
Divisione di Nefrologia, Dialisi e Ipertensione Ospedale San Raffaele
Milan, 20132, Italy
U.O. Nefrologia e Dialisi, Università degli Studi di Milano Azienda Ospedaliera San Paolo
Milan, 20142, Italy
Clinica Medica 3, Dipartimento di Scienze Mediche e Chirurgiche
Padua, 35128, Italy
Reparto Emodialisi, Clinica "Domus Nova"
Ravenna, 48100, Italy
Nefrologia e Dialisi, Ospedale Infermi
Rimini, 47900, Italy
Centro per l'Ipertensione, A.S.L. n° 1
Sassari, 07100, Italy
U.O. Nefrologia e Dialisi Presidio Ospedaliero "Giuseppe Mazzini"
Teramo, 64100, Italy
Centro Ipertensione Arteriosa, SCU Medicina Interna 4, A.O.U. San Giovanni Battista
Torino, 10126, Italy
Institute of Cardiology, Department of Coronary Disease, Jagiellonian University
Krakow, 31-202, Poland
Institute of Cardiology, I Department of Cardiology and Hypertension, Jagiellonian University
Krakow, 31-501, Poland
Internal Medicine and Gerontology, Jagiellonian University Medical College
Krakow, 31-501, Poland
Institute of Cardiology, Department of Hypertension, University of Medical Sciences
Poznan, 01-848, Poland
The Cardinal Stefan Wyszynski Institute of Cardiology - Arterial Hypertension Clinic
Warsaw, 04-628, Poland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jan A Staessen, MD PhD
Laboratory of Hypertension, University of Leuven, B-3000 Leuven - BELGIUM
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 16, 2011
First Posted
March 22, 2011
Study Start
May 1, 2011
Primary Completion
July 1, 2012
Study Completion
December 1, 2012
Last Updated
March 23, 2011
Record last verified: 2011-03