Status:
COMPLETED
Enhancement of Physical Activity in Elderly Patients With Diastolic Heart Failure by a Motivational Intervention
Lead Sponsor:
University of Göttingen
Collaborating Sponsors:
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
Conditions:
Diastolic Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The aim of our pilot study is to evaluate the feasibility, acceptance and efficacy of motivational interviewing (MI) to support elderly patients with heart failure with preserved ejection fraction (HF...
Detailed Description
Patients discharged from the Ex-DHF trial were recruited from June 2013 to December 2015 and offered participation in a controlled add-on pilot study. The treatment group (n=19) received 5 sessions of...
Eligibility Criteria
Inclusion
- preserved left ventricular systolic function (left ventricular ejection fraction \>= 50%),
- echocardiographically determined diastolic dysfunction (grade ≥ 1),
- New York Heart association functional classes I, II or III,
- at least one cardiovascular risk-factor (overweight, diabetes, hypertension, smoking or hyperlipidemia)
- participation in Ex-DHF main study
- written informed consent
Exclusion
- Non-cardiac causes for heart failure-like symptoms
- Chronic obstructive pulmonary disease GOLD stages ≥II
- Anaemia (haemoglobin \<11 mg/dL)
- Significant renal dysfunction (eGFR \<30 mL/min/1.73 m\*\*2 indexed to BSA)
- Significant peripheral artery disease (Fontaine ≥IIb)
- Musculoskeletal disease that contributes to reduced exercise performance
- Specific cardiomyopathy (e.g. amyloidosis)
- Haemodynamically significant valvular disorders
- Significant coronary artery disease (current angina pectoris Canadian Cardiovascular Society Class ≥II or positive stress test, myocardial infarction or coronary artery bypass graft within the last 3 months)
- Any inability or contraindication to participate in cardiopulmonary exercise testing or in an exercise programme (e.g. physiological, mental) or to supply essential information (e.g. questionnaire, diary)
- Ineffective control of resting blood pressure (≥140/90 mmHg or ≥160/100 mmHg with ≥3 antihypertensive drugs) or of resting heart rate (≥100 b.p.m.)
- Expected low adherence (e.g. by travel distance to trial site; planned absences longer than 4 weeks during follow-up) or ongoing drug abuse
- Pregnant or nursing women
- Concomitant participation in other interventional clinical trials
Key Trial Info
Start Date :
June 18 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 8 2015
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT03402490
Start Date
June 18 2013
End Date
December 8 2015
Last Update
January 18 2018
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