NCT03555318

Brief Summary

Randomized clinical trial in which patients with a recent admission for heart failure in the cardiology department of the Hospital de Mar will be randomized to usual follow-up (cardiologist of the Heart Failure Unit) or follow-up by cardiologist and intervention by the geriatrician. This visit will be done at the same time. The main gial of this study is to evaluate whether the combined intervention of a cardiologist and a geriatrician reduces hospital all-cause rehospitalizations at 1 year.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for not_applicable heart-failure

Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 7, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 13, 2018

Completed
1 day until next milestone

Study Start

First participant enrolled

June 14, 2018

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 5, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 5, 2020

Completed
Last Updated

November 6, 2020

Status Verified

November 1, 2019

Enrollment Period

2.4 years

First QC Date

May 7, 2018

Last Update Submit

November 5, 2020

Conditions

Heart Failure

Keywords

Heart failureFrailtyOutcomeHospitalizationMortality

Outcome Measures

Primary Outcomes (1)

  • Number of participants with all-cause hospitalization within the defined time points

    Number of participants with an all-cause hospitalization at 1 year follow-up

    1 year

Secondary Outcomes (6)

  • Number of participants with heart failure hospitalization within the defined time points

    1 year

  • Number of participants dead within the defined time points

    1 year

  • Change in quality of life measured with the Kansas City Cardiomyopathy Questionnaire (KCCQ) within the defined time points

    1 year

  • Change in functional capacity measured with the Barthel index within the defined time points

    1 year

  • Change in the number of participants with more than 5 medications (polypharmacy) within the defined time points

    1 year

  • +1 more secondary outcomes

Study Arms (2)

Geriatrician + Cardiologist

EXPERIMENTAL

Patients randomized to a combined ambulatory follow up with a cardiologist and a geriatrician.

Other: Combined ambulatory visitOther: Geriatric intervention

Cardiologist

ACTIVE COMPARATOR

Patients randomized to usual care (ambulatory follow up with a cardiologist).

Other: Ambulatory visit

Interventions

Ambulatory visitOTHER

All patients will have an ambulatory visit with the cardiologist.

Cardiologist
Combined ambulatory visitOTHER

Both the geriatrician and cardiologist will evaluate the patient and cardiac treatment will be agreed on between both specialists.

Geriatrician + Cardiologist
Geriatric interventionOTHER

After the geriatric assessment, measures to improve frailty will be started.

Geriatrician + Cardiologist

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Patients older than 75 years with a recent admission for heart failure (within the previous 10 days).

You may not qualify if:

  • Patients in palliative care.
  • Patients with chronic pathologies with expected life expectancy \<1 year.
  • Patients discharged to a skilled nursing facility
  • Patients with heart valve replacement during index admission

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital del Mar, Parc de Salut Mar

Barcelona, Non-USA, 08003, Spain

Location

Related Publications (2)

  • Luiso D, Herrero-Torrus M, Badosa N, Roqueta C, Ruiz-Bustillo S, Belarte-Tornero LC, Valdivielso-More S, Morales RO, Vazquez O, Farre N. Quality of Life in Older Patients after a Heart Failure Hospitalization: Results from the SENECOR Study. J Clin Med. 2022 May 27;11(11):3035. doi: 10.3390/jcm11113035.

    PMID: 35683423DERIVED

  • Herrero-Torrus M, Badosa N, Roqueta C, Ruiz-Bustillo S, Sole-Gonzalez E, Belarte-Tornero LC, Valdivielso-More S, Vazquez O, Farre N. Randomized Controlled Trial Comparing a Multidisciplinary Intervention by a Geriatrician and a Cardiologist to Usual Care after a Heart Failure Hospitalization in Older Patients: The SENECOR Study. J Clin Med. 2022 Mar 30;11(7):1932. doi: 10.3390/jcm11071932.

    PMID: 35407540DERIVED

MeSH Terms

Conditions

Heart FailureFrailty

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Nuria Farre, MD

    Institut Hospital del Mar d'Investigacions Mèdiques

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2018

First Posted

June 13, 2018

Study Start

June 14, 2018

Primary Completion

November 5, 2020

Study Completion

November 5, 2020

Last Updated

November 6, 2020

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)