Heart Transplant FailureNCT03671408
Levels of High-Sensitivity C-Reactive Protein in Heart Transplant Patients
An observational study of Heart Transplant Failure and Periodontitis, run by Baskent University.
Trial summary
Inflammation plays a key role in the deterioration of chronic heart transplants. Periodontal disease is not limited to the tooth-supporting structures - it also contributes to systemic inflammation. Read more about this study
- Who is it for?
- Ages 11 to 65 years
- Conditions the study is for
- Heart Transplant Failure, Periodontitis, Crp
- What is being tested?
- clinical measurements
- How many people
- 33 participants
- Where
- No sites listed yet
- Study dates
- 20 Apr 2016to 10 Jun 2018
- How long will I take part?
- 1 Day
- 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 11 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The patients who underwent heart transplant between 2004 and April 2016 at Baskent University Hospital,will be asked to participate in the study during routine outpaient visits at Baskent University Hospital
Who may be able to join
- Patients who underwent heart transplant procedures at Baskent University Hospital
Who cannot join
None listed.
About this study
Official title: Levels of High-Sensitivity C-Reactive Protein in Heart Transplant Patients With and Without Periodontitis
Inflammation plays a key role in the deterioration of chronic heart transplants. Periodontal disease is not limited to the tooth-supporting structures - it also contributes to systemic inflammation. This study explored whether periodontitis is associated with serum high-sensitivity C-reactive protein (hs-CRP) levels in heart transplant patients.
The study included 33 patients who had undergone heart transplantation at Baskent University Hospital. Clinical periodontal parameters were recorded, and blood samples were collected on the same day to measure serum hs-CRP.
Read the detailed description
Of the 33 patients, 9 (27.3%) had periodontitis, 4 (12.1%) were periodontally healthy, and 20 (60.6%) had gingivitis. Serum hs-CRP was significantly higher in the periodontitis group than in the healthy and gingivitis groups (P = .006). hs-CRP also correlated positively with probing depth (r = 0.358; P = .041), clinical attachment level (r = 0.352; P = .045), and gingival recession (r = 0.422; P = .014).
Elevated hs-CRP in heart transplant patients was associated with periodontitis, supporting the value of regular periodontal visits after transplant.
- Conditions
- Heart Transplant Failure, Periodontitis, Crp
- Being tested
- clinical measurements
- Keywords
- heart transplant, periodontitis, hsCRP
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clinical measurementsOther
Also called no intervention was made
only clinical parameters were recorded
| Study group | Role | What they receive |
|---|---|---|
| gingivitis/healthy | Description: "gingivitis healthy patients which were diagnosed based on clinical parameters Receives: Other: clinical measurements | |
| periodontitis | periodontitis patients which were diagnosed based on clinical parameters |
What is being measured
The primary outcome is the main question the study is designed to answer.
hs-CRP levels
Serum hs-CRP levels were compared between the groups (periodontitis vs. periodontally healthy vs. gingivitis)
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2018
- Study start20 Apr 2016
- Primary completion20 May 2018
- Study completion10 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Transplant 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 33 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasemin Sezgin, Baskent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03671408
- Sponsor's protocol ID
- BaskentU3
- Other IDs
- approval no. 16/02
- Status last verified
- Aug 2026
- First submitted
- 13 Sep 2018
- Last updated
- 4 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Levels of High-Sensitivity C-Reactive Protein in Heart Transplant Patients With and Without Periodontitis
- ClinicalTrials.gov ID
- NCT03671408
- Acronym / sponsor ID
- BaskentU3
- Conditions
- Heart Transplant Failure, Periodontitis, Crp
- Keywords
- heart transplant, periodontitis, hsCRP
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Study start
- 20 Apr 2016 (actual)
- Primary completion
- 20 May 2018 (actual)
- Study completion
- 10 Jun 2018 (actual)
- First posted
- 14 Sep 2018 (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.
Inflammation plays a key role in the deterioration of chronic heart transplants. Periodontal disease is not limited to the tooth-supporting structures - it also contributes to systemic inflammation. This study explored whether periodontitis is associated with serum high-sensitivity C-reactive protein (hs-CRP) levels in heart transplant patients.
The study included 33 patients who had undergone heart transplantation at Baskent University Hospital. Clinical periodontal parameters were recorded, and blood samples were collected on the same day to measure serum hs-CRP.
Detailed description
Of the 33 patients, 9 (27.3%) had periodontitis, 4 (12.1%) were periodontally healthy, and 20 (60.6%) had gingivitis. Serum hs-CRP was significantly higher in the periodontitis group than in the healthy and gingivitis groups (P = .006). hs-CRP also correlated positively with probing depth (r = 0.358; P = .041), clinical attachment level (r = 0.352; P = .045), and gingival recession (r = 0.422; P = .014).
Elevated hs-CRP in heart transplant patients was associated with periodontitis, supporting the value of regular periodontal visits after transplant.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| gingivitis/healthy | – | Other: clinical measurementsDescription: "gingivitis healthy patients which were diagnosed based on clinical parameters |
| periodontitis | – | –periodontitis patients which were diagnosed based on clinical parameters |
Who may qualify
- Ages
- 11 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The patients who underwent heart transplant between 2004 and April 2016 at Baskent University Hospital,will be asked to participate in the study during routine outpaient visits at Baskent University Hospital
Key inclusion criteria (1 listed)
- Patients who underwent heart transplant procedures at Baskent University Hospital
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| clinical measurementsAlso: no intervention was madeonly clinical parameters were recorded | Other | gingivitis/healthy |
Primary outcome
hs-CRP levels
Time frame: Day 1
Serum hs-CRP levels were compared between the groups (periodontitis vs. periodontally healthy vs. gingivitis)
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 4 Aug 2026.
- Individual participant dataSharing planned: No
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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 Heart Transplant Failure and Periodontitis, run by Baskent 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 1 inclusion and 0 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 4 Aug 2026. 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?
hs-CRP levels (time frame: Day 1). 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 4 Aug 2026.