NCT04790214

Brief Summary

CARECA-CHF study is a non-randomized, prospective, single-arm study, enrolled ambulatory patients with stable chronic heart failure \[New York Heart Association (NYHA) class II/III\]. Patients will be followed-up during a period of 06-08 weeks. The aim of this study is to assess the effect of a cardiac rehabilitation program on patients with stable chronic heart failure in Yaoundé, Cameroon.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

February 25, 2021

Completed
4 days until next milestone

Study Start

First participant enrolled

March 1, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 10, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

March 10, 2021

Status Verified

March 1, 2021

Enrollment Period

3 months

First QC Date

February 25, 2021

Last Update Submit

March 4, 2021

Conditions

Keywords

Cardiac rehabilitationChronic Heart failurePhysical functionCameroon

Outcome Measures

Primary Outcomes (1)

  • Change of VO2 max

    Variation of VO2 max at baseline and the end of the study

    8 weeks

Secondary Outcomes (10)

  • Variation in 6-minute walk test (6MWT) distance

    8 weeks

  • Variation of duration of exercise and maximum load

    8 weeks

  • Variation in level of anxiety and depression;

    8 weeks

  • Change in quality of life assessed by the Minnesota Living With Heart Failure Questionnaire (MLWHFQ)

    8 weeks

  • Variation of time-domain heart rate variability (HRV) parameters

    8 weeks

  • +5 more secondary outcomes

Study Arms (1)

Stable CHF patients

EXPERIMENTAL

Stable CHF patients on stage II/III based on the New York Heart Failure classification

Other: CHF Patients

Interventions

Cardiac rehabilitation program on CHF patients on 06-08 weeks. Program will include: physical aerobic re-training, therapeutic education on CHF, psychological follow-up, nutritional education

Stable CHF patients

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with stable chronic heart failure confirmed by a cardiac ultrasound and whose severity is rated stage II or III of NYHA followed at Yaoundé central hospital and Yaoundé general hospital;
  • Stable under treatment;
  • Whose cardiac ultrasound is less than six months old;
  • Having given his free and informed consent.

You may not qualify if:

  • Poor adherence to the cardiac rehabilitation program activities;
  • Patients lost insight the program;
  • Withdrawal of informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr Chris Nadège Nganou-Gnindjio

Yaoundé, BP: 35307 Bastos, Cameroon

Location

Study Officials

  • Chris Nadège N Nganou-Gnindjio, MD, MAS

    Yaounde Central Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: Patients with stable CHF in stage II or III of the New York Heart Association.
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr, Principal investigator

Study Record Dates

First Submitted

February 25, 2021

First Posted

March 10, 2021

Study Start

March 1, 2021

Primary Completion

June 1, 2021

Study Completion

September 1, 2021

Last Updated

March 10, 2021

Record last verified: 2021-03

Locations