Chronic Heart FailureNCT04352426
Symptom-limited Stair Climbing Test in Heart Failure
An observational study of Chronic Heart Failure, run by KTO Karatay University.
Trial summary
Aims: To assess the efficacy of symptom-limited stair-climbing test (SLSCT), in determining the exercise capacities of patients with chronic heart failure (CHF) in comparison with cardiopulmonary exercise test (CPET) and 6-minute walk test(6MWT) and to interpret the results according to the clinical status of the… Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Heart Failure
- What is being tested?
- Exercise Test
- How many people
- 31 participants
- Where
- No sites listed yet
- Study dates
- 13 Jan 2017to 12 Nov 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Thirty-one patients age 65.52±7.57 years with stage II-III according to the NYHA classification, diagnosed with CHF, with a LVEF of 45% or less admitted to study.
Who may be able to join
- 50-75 years of age
- NYHA stage II-III
- LVEF of 45% or less
- Independently walking and climbing stairs
- Volunteer to participate in research
Who cannot join
- Any acute or chronic condition that would limit exercise capacity other than CHF
- Insufficient mental status to perform tests and surveys
- Orthopaedic problem limiting exercise test in lower extremity
- Severe obesity or there is a secondary cause for obesity
- Uncontrolled cardiac arrhythmia
- Unstable angina
About this study
Official title: Effectiveness of Symptom-limited Stair-climbing Test in the Determination of the Exercise Capacity of Patients With Chronic Heart Failure
Aims: To assess the efficacy of symptom-limited stair-climbing test (SLSCT), in determining the exercise capacities of patients with chronic heart failure (CHF) in comparison with cardiopulmonary exercise test (CPET) and 6-minute walk test(6MWT) and to interpret the results according to the clinical status of the patients.
Methods: Thirty-one patients, aged 50-75 years, with stage II-III CHF according to the New York Heart Association Classification and left ventricular ejection fraction (LVEF) of ≤45% were included. The demographic and clinical characteristics of the patients were recorded. Exercise capacity was assessed by SLSCT, 6MWT, and CPET. The duration of patients' performance in the test, reasons for ending the test and predicted maximal oxygen consumption (VO2max) were recorded. Heart rate (HR), blood pressure (BP), dyspnoea severity [Modified Borg Scale (MBS)] and peripheral oxygen saturation were recorded. Pulmonary functions were assessed by spirometry.
- Conditions
- Chronic Heart Failure
- Being tested
- Exercise Test
- Keywords
- chronic heart failure, exercise capacity, symptom-limited stair-climbing test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise TestOther
Tests were conducted to evaluate exercise capacity.
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom-Limited Stair-Climbing Test(SLSCT)
predicted VO2 max (ml/kg/min)
Measured: baseline
Six-Minute Walk Test(6MWT)
predicted VO2 max (ml/kg/min)
Measured: baseline
Cardiopulmonary Exercise Test(CPET)
predicted VO2 max (ml/kg/min)
Measured: baseline
Secondary outcomes (3)
Heart Rate
Heart Rate beats/min
Measured: immediately after the procedure
Left Ventricular Ejection Fraction
Ecocardiography
Measured: baseline
Blood Pressure
Systolic and diastolic blood pressure (mmHg)
Measured: immediately after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2020
- Study start13 Jan 2017
- Primary completion10 Nov 2017
- Study completion12 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- KTO Karatay University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04352426
- Sponsor's protocol ID
- busra.alkan
- Status last verified
- Apr 2020
- First submitted
- 6 Apr 2020
- Last updated
- 20 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Symptom-limited Stair-climbing Test in the Determination of the Exercise Capacity of Patients With Chronic Heart Failure
- ClinicalTrials.gov ID
- NCT04352426
- Acronym / sponsor ID
- busra.alkan
- Conditions
- Chronic Heart Failure
- Keywords
- chronic heart failure, exercise capacity, symptom-limited stair-climbing test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- KTO Karatay UniversityUniversity, hospital or other
- Study start
- 13 Jan 2017 (actual)
- Primary completion
- 10 Nov 2017 (actual)
- Study completion
- 12 Nov 2017 (actual)
- First posted
- 20 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aims: To assess the efficacy of symptom-limited stair-climbing test (SLSCT), in determining the exercise capacities of patients with chronic heart failure (CHF) in comparison with cardiopulmonary exercise test (CPET) and 6-minute walk test(6MWT) and to interpret the results according to the clinical status of the patients.
Methods: Thirty-one patients, aged 50-75 years, with stage II-III CHF according to the New York Heart Association Classification and left ventricular ejection fraction (LVEF) of ≤45% were included. The demographic and clinical characteristics of the patients were recorded. Exercise capacity was assessed by SLSCT, 6MWT, and CPET. The duration of patients' performance in the test, reasons for ending the test and predicted maximal oxygen consumption (VO2max) were recorded. Heart rate (HR), blood pressure (BP), dyspnoea severity [Modified Borg Scale (MBS)] and peripheral oxygen saturation were recorded. Pulmonary functions were assessed by spirometry.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Thirty-one patients age 65.52±7.57 years with stage II-III according to the NYHA classification, diagnosed with CHF, with a LVEF of 45% or less admitted to study.
Key inclusion criteria (5 listed)
- 50-75 years of age
- NYHA stage II-III
- LVEF of 45% or less
- Independently walking and climbing stairs
- Volunteer to participate in research
Key exclusion criteria (6 listed)
- Any acute or chronic condition that would limit exercise capacity other than CHF
- Insufficient mental status to perform tests and surveys
- Orthopaedic problem limiting exercise test in lower extremity
- Severe obesity or there is a secondary cause for obesity
- Uncontrolled cardiac arrhythmia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise TestTests were conducted to evaluate exercise capacity. | Other | – |
Primary outcome
Symptom-Limited Stair-Climbing Test(SLSCT)
Time frame: baseline
predicted VO2 max (ml/kg/min)
Six-Minute Walk Test(6MWT)
Time frame: baseline
predicted VO2 max (ml/kg/min)
Cardiopulmonary Exercise Test(CPET)
Time frame: baseline
predicted VO2 max (ml/kg/min)
3 secondary outcomes
Heart Rate
Time frame: immediately after the procedure
Left Ventricular Ejection Fraction
Time frame: baseline
Blood Pressure
Time frame: immediately after the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Heart Failure, run by KTO Karatay University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom-Limited Stair-Climbing Test(SLSCT) (time frame: baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2020.