Condition category
Circulatory System
Date applied
04/07/2007
Date assigned
27/09/2007
Last edited
01/11/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Frank Edelmann

ORCID ID

Contact details

Robert- Koch- Str. 40
Gottingen
37073
Germany
+49 (0)551 392658
fedelmann@med.uni-goettingen.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Ex-DHF-P

Study hypothesis

Supervised combined endurance and strength exercise training for three months, two to three times/week improves the exercise capacity and quality of life in patients with diastolic heart failure compared to patients in a non-training control group.

Please note that as of 01/11/2007 this trial has now been completed. The previous anticipated end date of this trial was 30/09/2008.

Ethics approval

Ethics approval received from the ethics committees of the Universities of Gottingen, Berlin, Munich (Germany) on the 14th September 2006 (ref: 38/9/06), following by amendment 1 on 22nd January 2007 and amendment 2 on 7th March 2007.

Study design

Multicentre, prospective, randomised, controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Quality of life

Patient information sheet

Condition

Diastolic Heart Failure

Intervention

Once randomised, patients will either participate in an combined endurance and strength exercise training two to three times/week for three months or perform their usual activities. After three months and the second visit all patients participate in the training for another three months.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Change in peak maximal oxygen uptake (VO2), measured at three months.

Secondary outcome measures

1. Change in quality of life
2. Change in early left ventricular filling-to-peak early diastolic myocardial velocity ratio (E/E' ratio)
3. Change in six-minute walking distance
4. Change in N-Terminal pro-B-type Natriuretic Peptide (NT-proBNP) and other parameters of neurohumoral activation
5. Change in Heart Rate Variability (HRV) and Heart Rate Turbulence (HRT)
6. Change in blood levels of parameters of collagen turnover, metabolic syndrome and inflammation
7. Change in parameters of diastolic dysfunction:
7.1. Early-to-Atrial left ventricular filling ratio (E/A ratio)
7.2. Early left ventricular filling Deceleration Time (EDT)
7.3. Isovolumic Relaxation Time (IVRT)
7.4. Systolic-to-Diastolic pulmonary venous flow ratio (S/D ratio)
7.5. Pulmonary Venous peak Atrial contraction Reversed velocity (PVAR)
7.6. Colour M-Mode flow propagation Velocity (Vp)
7.7. Doppler echocardiography-derived index of myocardial performance (TEI-Index)
7.8. Left Ventricular mass (LV-mass)
7.9. Left Ventricular volume (LV-volume)
7.10. Left Atrial volume (LA-volume)
8. Severity of diastolic dysfunction (echocardiography)
9. Change in endothelial function, safety, compliance, cardiovascular morbidity and mortality

Secondary outcomes are measured at three and six months.

Overall trial start date

01/10/2006

Overall trial end date

01/11/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. At least one of the following risk factors for the development of a diastolic dysfunction:
1.1. Diabetes
1.2. Hypertension
1.3. Smoking
1.4. Hyperlipidaemia
1.5. Overweight
2. Aged greater than or equal to 45 years
3. Written informed consent
4. New York Heart Association (NYHA) II or III
5. Diastolic dysfunction greater than or equal to grade one (echocardiographically determined)
6. Left Ventricular Ejection Fraction (LVEF) greater than or equal to 50%

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

60 (40 versus 20)

Participant exclusion criteria

1. Diseases limiting the validity of consent (psychiatric diseases, dementia etc.,)
2. Change in medication within the last two weeks
3. Limited exercise capacity due to musculo-skeletal diseases or pulmonary disease
4. Myocardial Infarction (MI) or bypass surgery in the patient's history or clinically significant Coronary Artery Disease (CAD) (angina or known untreated stenosis of more than 50%) or peripheral arterial obstructive disease greater than or equal to IIa
5. Pregnant or nursing women and women before menopause without sufficient contraception
6. Participaton in another study currently or within the last 30 days

Recruitment start date

01/10/2006

Recruitment end date

01/11/2007

Locations

Countries of recruitment

Germany

Trial participating centre

Robert- Koch- Str. 40
Gottingen
37073
Germany

Sponsor information

Organisation

Georg-August University of Gottingen (Georg-August-Unversitat Gottingen) (Germany)

Sponsor details

c/o Professor Dr Burkert Pieske
Robert- Koch- Str. 40
Gottingen
37073
Germany
pieske@med.uni-goettingen.de

Sponsor type

University/education

Website

http://www.uni-goettingen.de/en/sh/1.html

Funders

Funder type

Government

Funder name

German Federal Ministry of Education and Research (Bundesministerium Für Bildung und Forschung [BMBF]) (Germany) - Health Research, Competence Network on Heart Failure

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes