To determine the kidney function in patients before and after enhanced external counterpulsation treatment

ISRCTN	ISRCTN11560035
DOI	https://doi.org/10.1186/ISRCTN11560035
Protocol serial number	N/A
Sponsor	Piyavate Hospital (Thailand)
Funders	This is an investigator-initiated study, carried out in collaboration with the following hospitals:, Piyavate Hospital (Thailand), Ramathibodi Hospital (Thailand)

Submission date: 25/10/2009
Registration date: 17/11/2009
Last edited: 23/07/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Prajej Ruangkanchanasetr
Scientific

Assistant Professor, Division of Nephrology
Department of Medicine
Phramongkutklao Hospital (Royal Thai Army Hospital)
315 Rajavithi Road
Rajathevi
Bangkok
10240
Thailand

Phone	+66 (0)2 644 4676
Email	prajej@gmail.com

Study information

Primary study design	Observational
Study design	Single-centre observational study
Secondary study design	Single-centre
Study type	Participant information sheet
Scientific title	To determine the kidney function by using serum cystatin C in patients before and after enhanced external counterpulsation treatment
Study objectives	Enhanced external counterpulsation (EECP) is based on the principle of diastolic augmentation to increase coronary flow while simultaneously decreasing systolic afterload. We proposed that EECP treatment could improve cardiac function, therefore might improve kidney function. The aim of the trial is to see whether EECP treatment can slow the progression of kidney disease in patients with ischemic heart disease and congestive heart failure.
Ethics approval(s)	Institutional Review Board of Piyavate Hospital, approved on 25/10/2006 (ref: 006/2006)
Health condition(s) or problem(s) studied	Ischaemic heart disease, chronic stable angina, chronic stable heart failure
Intervention	All patients will receive EECP typically involving 35 x 1-h sessions of counterpulsations over a 7-week period.
Intervention type	Other
Primary outcome measure(s)	Serum cystatin C All primary and secondary outcome measures will be assessed before and within 1 month, and 5-7 months after completion of EECP treatment of 35 sessions.
Key secondary outcome measure(s)	1. Calculated glomerular filtration rate (GFR) 2. Serum N-Terminal pro-B-type Natriuretic Peptide (NT-proBNP) 3. Ejection fraction determined by echocardiography All primary and secondary outcome measures will be assessed before and within 1 month, and 5-7 months after completion of EECP treatment of 35 sessions.
Completion date	30/11/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	26
Key inclusion criteria	1. Both males and females, age >18 years 2. Patients with refractory angina, chronic stable angina or chronic stable heart failure 3. Willing to participate in the study with informed consent
Key exclusion criteria	1. Patient with the diagnosis of congestive heart failure within 1 month prior to study entry 2. Patient with the diagnosis of acute coronary syndrome within 1 month prior to study entry 3. Patient with uncontrolled blood pressure (>180/110 mmHg) 4. Patient with cardiac arrhythmia (e.g. atrial fibrillation or atrial flutter or frequent premature ventricular contractions) that may interfere with triggering of EECP system 5. Patients with severe lower extremity vaso-occlusive disease 6. Patients with end stage renal disease requiring renal replacement therapy
Date of first enrolment	01/11/2006
Date of final enrolment	30/11/2009

Locations

Countries of recruitment

Thailand

Study participating centre

Assistant Professor, Division of Nephrology

Bangkok
10240
Thailand

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	11/09/2013		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes