Contact information
Type
Scientific
Primary contact
Dr Prajej Ruangkanchanasetr
ORCID ID
Contact details
Assistant Professor
Division of Nephrology
Department of Medicine
Phramongkutklao Hospital (Royal Thai Army Hospital)
315 Rajavithi Road
Rajathevi
Bangkok
10240
Thailand
+66 (0)2 644 4676
prajej@gmail.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
To determine the kidney function by using serum cystatin C in patients before and after enhanced external counterpulsation treatment
Acronym
Study hypothesis
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
Institutional Review Board of Piyavate Hospital, approved on 25/10/2006 (ref: 006/2006)
Study design
Single-centre observational study
Primary study design
Observational
Secondary study design
Single-centre
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measure
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.
Secondary outcome measures
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.
Overall trial start date
01/11/2006
Overall trial end date
30/11/2009
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
26
Participant 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
Recruitment start date
01/11/2006
Recruitment end date
30/11/2009
Locations
Countries of recruitment
Thailand
Trial participating centre
Assistant Professor, Division of Nephrology
Bangkok
10240
Thailand
Sponsor information
Organisation
Piyavate Hospital (Thailand)
Sponsor details
c/o Dr Prajej Ruangkanchanasetr
998 Rimklongsamsen Rd (Rama 9 Rd)
Bangkapi
Huaykwang
Bangkok
10310
Thailand
+66 (0)81 311 7815
prajej@gmail.com
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
This is an investigator-initiated study, carried out in collaboration with the following hospitals:
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Piyavate Hospital (Thailand)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Ramathibodi Hospital (Thailand)
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
Basic results (scientific)
Publication list
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24021027
Publication citations
-
Results
Ruangkanchanasetr P, Mahanonda N, Raungratanaamporn O, Ruckpanich P, Kitiyakara C, Chaiprasert A, Adirekkiat S, Punpanich D, Vanavanan S, Chittamma A, Supaporn T, Effect of enhanced external counterpulsation treatment on renal function in cardiac patients., BMC Nephrol, 2013, 14, 193, doi: 10.1186/1471-2369-14-193.